Further study details as provided by Translational Research Institute for Metabolism and Diabetes, Florida:

Primary Outcome Measures:

Difference of angiogenesis capacity in abdominal and gluteal adipose tissue [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

The angiogenesis capacity of each adipose tissue depot will be determine by an in vitro angiogenesis test.

Secondary Outcome Measures:

Presence of biomarkers in abdominal and gluteal adipose tissue in obese and PCOS women [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Measurement will be obtained with Fluorescence-activated cell sorting (FACS).

Identify different and similar biomarkers in obese and PCOS women, from abdominal and gluteal adipose tissue samples. Total RNA, micro RNA and DNA will be extracted from each type of cells using FACS-cell sorting analysis.

Difference in oxygen content of abdominal and gluteal adipose tissue [ Time Frame: Day 6 ] [ Designated as safety issue: No ]

Adipose tissue oxygen content will be measured using the Licox CMP microprocessor.

Other Outcome Measures:

The rates of carbohydrate oxidation [ Time Frame: Day -7 ] [ Designated as safety issue: No ]

Study Population and screening: Healthy young women with a BMI > 30 will be recruited; 12 will have a gynoid pattern as defined by a waist-to-hip ratio less than 0.78 and 12 with an android pattern as defined by a waist-to-hip greater than 0.85. A third group will include 12 women with PCOS as defined by the NIH criteria. Subjects will be recruited via a dedicated website, physician referrals, direct mail outs, newspaper advertisements, and brochures. Only subjects that will sign informed consent and meet eligibility criteria will be enrolled in this study.

Criteria

Inclusion Criteria:

Female

Age > 20 and < 40

Weight stable (change of less than 3 kg in the last 8 weeks)

BMI < 40 kg/m2 or > 27 kg/m2

Supplemental inclusion criteria for PCOS women:

NIH criteria - confirmed by subjects' medical records.

Exclusion Criteria:

Male

Women who are pregnant or lactating (breast feeding)

Post-menopausal women

Women with hysterectomy

Diagnosed with diabetes, or have a fasting blood sugar > 126 mg/dL.

Untreated or symptomatic thyroid disease.

Impaired kidney or liver function, as evidenced by your blood work

Hypertension/ high blood pressure or are taking blood pressure medications

Use of oral contraceptives or hormone replacement therapy.

History of drug or alcohol abuse (> 3 drinks per day) in the last 5 years, or psychiatric disease prohibiting adherence to study protocol.

History of cancer within the last 5 years.

History of organ transplant.

History of HIV, active Hepatitis B or C, or Tuberculosis.

History of heart attack/ myocardial infarction.

Presence of clinically significant abnormalities on EKG.

Current smokers (smoking within the past 3 months)

Use of any medications known to influence glucose, fat and/or energy metabolism within the last 3 months (e.g., growth hormone therapy, glucocorticoids [steroids], etc.). Metformin for women with PCOS is allowed.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745471